Expanding access to BNP assay

The B-type Natriuretic Peptide (BNP) serves a direct biological response to cardiovascular stress, allowing a fast representation of a patient's cardiac situation and more timely treatment

Bayer Diagnostics and Olympus Life and Material Science Europa have signed a non-exclusive supply and distribution agreement in the diagnostics testing arena.

The agreement will expand access to Bayer Diagnostics's automated assay for B-type Natriuretic Peptide (BNP) testing.

Recent research has shown that elevated levels of BNP indicate the presence of heart failure, thus providing physicians with an important diagnostic tool in the early detection and management of heart failure (HF).

Olympus will optimise Bayer Diagnostics's BNP assay for use on the new Olympus AU3000i, which is currently scheduled for release in 2005 in Europe and 2006 in the United States, pending clearance from the Food and Drug Administration (FDA).

Bayer Diagnostics plans to file for clearance from the FDA and manufacture product for Olympus's direct distribution to its diagnostics customers worldwide except Japan.

"The rapid acceptance of BNP testing by physicians in the diagnosis and prognosis of heart failure patients has been unprecedented," stated Helmut Koehler, managing director of Olympus Life and Material Science.

"The ability to offer BNP on our AU3000i immunochemistry system is of enormous importance.

"Bayer Diagnostics is in a fortunate position to enable other diagnostics manufacturers access to the BNP assay.

"The BNP assay is an example of Bayer's ongoing commitment to improving life through scientific innovation.

"Providing the BNP assay to additional diagnostics vendors will help drive the benefits of BNP testing to patients and healthcare providers globally".

B-type Natriuretic Peptide or BNP is a rapidly expanding area for cardiovascular testing.

The BNP molecule is physiologically active, serving as a direct biological response to cardiovascular stress.

This attribute allows BNP testing to provide a representation of a patient's cardiac situation at the time a blood sample is drawn, which in turn, allows for more timely treatment and patient management.

The use of BNP as an effective tool in the prognosis and management of heart failure makes it the molecule of choice versus NT-proBNP in the majority of leading heart and heart surgery hospitals in the United States (as identified by the US News and World Report).

Bayer Diagnostics's BNP Assay.

Bayer Diagnostics, in 2003, received FDA clearance for its fully-automated BNP test as an aid in the diagnosis of heart failure.

The following year, Bayer Diagnostics received FDA clearance for two added claims - the prediction of survival in patients after myocardial infarction, and assessment of heart failure severity in patients diagnosed with congestive heart failure.

In May 2005, two additional claims received 510(k) clearance; in patients with acute coronary syndromes (ACS), the BNP assay, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.

Bayer Diagnostics licensed BNP directly from Shionogi Corporation in Japan.

Bayer's in vitro diagnostic test for the quantitative determination of BNP is available for worldwide use on the Bayer Advia Centaur, the ACS:180 immunoassay systems and, pending FDA clearance, will be available on the Olympus AU3000i system.

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